Clinical trial for Metastatic Colorectal Cancer
Official title A Study to Investigate CEA-PRIT 2.0 in Participants With Metastatic Colorectal Cancer (mCRC)
ClinicalTrials.gov ID: NCT07416552
What this study is testing
What is SPLIT Abs?
An investigational drug being studied as a potential treatment for metastatic colorectal cancer.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study will look at how the drug behaves in the body, how safe it is, and whether it shows any signs of working in patients with metastatic colorectal cancer that is microsatellite-stable.
- Who it's for
- It is for adults with metastatic colorectal cancer who cannot tolerate or whose disease has progressed after standard treatments.
- What's involved
- Participants will receive the CEA-PRIT 2.0 treatment and will have blood tests, scans, and other safety checks to monitor the drug’s effects.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Histologically confirmed adenocarcinoma originating from the colon or rectum
- Metastatic disease (Stage IV American Joint Committee on Cancer, Version 7)
- Confirmed MSS and/or proficient mismatch repair (MMR) status
- Experienced disease progression during or within 3 months following the last administration of systemic anti-cancer therapies for metastatic disease
- Presence of measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
You likely can't join if
- Pregnant or breastfeeding or intending to become pregnant
- Participants with active central nervous system (CNS) metastases
- History of malignancy other than the one under investigation
- Any unresolved toxicities from prior therapy, i.e., radiotherapy, chemotherapy, targeted therapy or surgical procedure
- Major surgery or significant traumatic injury \<4 weeks prior to the first CEA-PRIT 2.0 administration (excluding biopsies) or anticipation of the...
- Participants have a known confirmed positive test for HIV
See the full eligibility criteria
- Histologically confirmed adenocarcinoma originating from the colon or rectum
- Metastatic disease (Stage IV American Joint Committee on Cancer, Version 7)
- Confirmed MSS and/or proficient mismatch repair (MMR) status
- Experienced disease progression during or within 3 months following the last administration of systemic anti-cancer therapies for metastatic disease
- Presence of measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
- Life expectancy estimated by the Investigator to be \>=12 weeks
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1
- Adequate cardiovascular, hematological and renal function and laboratory parameters
- Pregnant or breastfeeding or intending to become pregnant
- Participants with active central nervous system (CNS) metastases
- History of malignancy other than the one under investigation
- Any unresolved toxicities from prior therapy, i.e., radiotherapy, chemotherapy, targeted therapy or surgical procedure
- Major surgery or significant traumatic injury \<4 weeks prior to the first CEA-PRIT 2.0 administration (excluding biopsies) or anticipation of the need for major surgery during study treatment
- Participants have a known confirmed positive test for HIV
- Positive hepatitis B surface antigen (HBsAg) test, and/or positive total hepatitis B core Ab (HBcAb) test at screening.
- Positive hepatitis C (HCV) Ab test result at screening
- Any anticancer treatment or any investigational agent within 4 weeks (or 5 times the half-life, whichever is shorter) prior to C1D1
- Prior treatment with a CEA-targeted agent or systemic radio therapy
The study team makes the final eligibility decision.
Where it is enrolling
- Chicago, Illinois, United States
- St Louis, Missouri, United States
- Omaha, Nebraska, United States
- Houston, Texas, United States
- Madison, Wisconsin, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Chicago, Illinois, United States; St Louis, Missouri, United States; Omaha, Nebraska, United States; Houston, Texas, United States; Madison, Wisconsin, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.